Botswana- Statutory law - Animal health
Animal Health
Botswana
SUMMARY
Botswana laws on animal health are comprehensive. The primary legislation regulating this sector are Diseases of Animals Act, 1977 and Diseases of Animals Stock Regulations, 1926. They provide for the prevention and control of diseases of animals; importation, exportation and movement of animals; and the provision of quarantine of animals. The Diseases of Animals Act obliges every owner or person in control of any animal affected or suspected of being affected by any disease (listed in the Act) to report to the nearest departmental officer, administrative officer, or police officer and to isolate such animal. Movement and selling of diseased animals is prohibited. The Director of the Department of Veterinary Services can declare any area to an infected are. After this declaration, the authorities may impose the following measures: restricting movement of animals to and from the infected areas; isolation of infected animals; and ordering inoculation, dipping, treating or slaughtering of animals for the purpose of disease control. Specifically, when a place is declared as infected with Foot and Mouth Disease (FMD), the movement of cloven hooved animals in the infected areas is restricted. Persons leaving infected areas are expected to comply with reasonable precautions for preventing the spread of disease. Animals killed for diseases control purposes are compensated.
The Minister can declare certain areas as stock-free zones for the purposes of controlling diseases. Fences may be erected and maintained, and the sinking of boreholes within 8 km of any fence is prohibited. These zones act as buffer zones and the fences condones movement of animals from one zone to another. As part of disease control measures, the law empowers veterinary inspectors to vaccinate animals. The Public Health Act, 2014 empower the Director of Health Services to declare a public health emergency where animal diseases affect public health. The importation of stock and wild animals requires a permit. In case of stock, the importer may be requested to present a certificate from a government veterinary surgeon of the country of origin. Similarly, a permit is required to import into or transport through or re-export from Botswana any wild animal, or trophy, meat, or eggs thereof. The Diseases of Animals Act require all prospective stock exporters of animals to be authorised by the Director, while the Control of Livestock Industry Act require prospective exporters of cattle to be registered and authorised by the Director of Veterinary Services. Similarly, the WCNPA require prospective exporters of wildlife products to get a permit be authorised by the Director of Wildlife and National Parks.
The manufacturing, selling, distribution, importation, and exportation of Veterinary Medical Products (VMPs) are regulated by the Medicines and Related Substances Act, 2013 and Medicines and Related Substances Regulations of 2019 and complemented by Guidelines issues by Botswana Medicines Regulatory Authority (BOMRA). All establishment that manufactures and dispenses WMPs must be licensed. To ensure safety and quality of VMPs, the law require manufactures of medicines to supply to BOMRA all information which indicates that the premises to be used are suitable for the purpose and will be operated in accordance with standards of good practice in the manufacture and quality control of medicines. BOMRA provides guidelines (Guideline for Good Manufacturing Practice- Document No: BOMRA/IL/IL/P08/G01) to all licensed and prospective manufacturers on the requirements for current Good Manufacturing Practice (cGMP). The Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 - Document No: BOMRA/IL/IL/P03/G01 indicate medicines that may only be taken on prescription. Veterinary surgeons are permitted to prescribe VPMs to all animals whether under their care or not, and a copy of the prescription is to be left for a period of one year. prescribers to keep a copy of each issued prescription. Upon being aware of a safety, efficacy or quality problem which could have detrimental effects on public health, BOMRA or holder of market authorisation may recall concerned VMPs.
The import, export, distribute or sell medicines require a licence and shall be under the continuous supervisory control of a veterinary surgeon. The Medicines and Related Substances Regulations as read with the Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 provides the legal framework on importing VMPs. The importation of all consignments of medicinal products is channelled through the designated ports of entry and are cleared by customs and the Ministry of Health (Port health) in consultation with BOMRA. Upon arrival at the ports, the medicines are inspected by BOMRA, and Port Health Officers to ensure that they comply with the approved specifications and regulations before they are released. The Customs Act, 2018 empowers the Commissioner General of BURS to arrange for destruction of VMPs to safeguard public health.
The veterinary profession is regulated by the Veterinary Surgeons Act, 2011. All veterinarians must train as such and registered with the Veterinary Surgeon Council. The functions of registered veterinarians include purchasing, keeping, using, prescribing or supplying without licence, any goods, poisons or drugs required solely for the treatment of animals under his or her care in the course of his or her practice.
The Department of Veterinary Services is key in disease control and prevention in Botswana. The Departmental officers have numerous powers such as instructing the owner of any stock to assemble such stock or any part thereof at any specified place for the purpose of inspection or inoculation. The Minister's powers include establishing quarantine stations and declaring stock-free zones for the purpose of disease control. The Veterinary Surgeon Council registration of Veterinary surgeons and encourages and promotes efficiency in the practice of veterinary medicines, while the Botswana Medicines Regulatory Authority is responsible for regulation all medicines and related substances in Botswana, including veterinary medical products. District Councils have the power to protect public health at the district level, including declaring infected zones and enforcing regulations. The Public Health Act outlines the powers of various health officials, including the Minister of Health, Director of Health Services, and Health Officers, in preventing and addressing communicable diseases. The Botswana Unified Revenue Service plays a role in importation and exportation of veterinary medicines, with the authority to refuse importation and order destruction if necessary.
The Medicines and Related Substances Regulations allow for collaboration between different authorities to establish guidelines for efficient importation and exportation of medicines. The Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 and the Guideline for facilitation at Port of Entry, 2021 - Document No: BOMRA/IL/IE/P05/G03 specify the roles of customs officials, Port Health Officials, and the Botswana Medicines Regulatory Authority (BOMRA) to ensure smooth operations at ports of entry. Customs will be the first point of contact for imported medicines, and BURS will forward the consignment to Port Health for verification and inspections. The Public Health Act enables cooperation between the Director of Health Services and local authorities in appointing environmental health officers who are responsible for controlling environmental health matters. The Director also works with customs, immigration, and other relevant authorities to establish points of entry for port health services.
GENERAL PROVISIONS
The veterinary profession is mainly regulated by the Veterinary Surgeons Act (VSA),2011. This Act defines the term "veterinary surgery" as including the practice of veterinary medicine, and the giving or providing of any treatment, test, advice, diagnosis, or attention such as is normally performed, given or provided by veterinary surgeons at an established location. A "para-professional' is defined as a person other than a veterinary surgeon who is authorised by the Veterinary Surgeon Council to carry out designated duties to veterinary medicine under the supervision of a veterinary surgeon. Section 3 of the VSA establishes the Veterinary Surgeon Council which regulate veterinary professionals.
VETERINARIANS
The Veterinary Surgeon Act requires all veterinarians to be registered. As per section 7 of the VSA, it is an offence to perform functions of a veterinarian unless registered. The minimum qualification for veterinary surgeons is a degree while for paraprofessionals, it is diploma from a recognised institute. Further to this the Council may require that the applicant sit for an examination in order to satisfy itself that the applicant has the requisite knowledge and skill to qualify him or her for registration to practise veterinary surgery in Botswana. Also, written evidence is needed indicating that the applicant is a person of good character and repute, and a fit and proper person to be registered as a veterinary surgeon. The applicant must indicate the names and addresses of three referees known to him/her for at least two years and who would be prepared to certify in respect of the applicant's character and reputation to the Council. In Botswana, an individual cannot be registered as a veterinary surgeon under the following circumstances. First, if they have been struck off the register of any registering authority for veterinary surgeons outside Botswana and have not been reinstated. Second, if the Council or the High Court in Botswana, or any equivalent body or court outside Botswana, has not ordered the restoration of their name to the Register. This regulation ensures that only qualified and duly authorized veterinary surgeons are eligible for registration in Botswana. Section 44 allows revocation of the license of a veterinary surgeon if he/she is convicted of an offence under the VSA.
The functions of a registered veterinarian are prescribed in the Act and may include purchasing, keeping, using, prescribing or supplying without licence, any goods, poisons or drugs required solely for the treatment of animals under his or her care in the course of his or her practice. The functions that may be performed by non-veterinarians are specified in the Act. These are listed in Schedule 1; Part III and they include rendering of first aid for the purpose of saving an animal's life or relieving pain and performing operations as prescribed in the Schedule.
VETERINARY PARA-PROFESSIONALS
The Veterinary Surgeon Act defines a veterinary para-professional to mean a person, other than a veterinary surgeon, authorised by the Council to carry out designated duties relating to veterinary medicine under the supervision of a veterinary surgeon. A list of para-professionals is maintained by the Veterinary Surgeons Council. Part II of the Veterinary Surgeon Act list functions that may be done by unqualified persons, that is, para-professionals and such include offering medical treatment as regulated by the Act; vaccination; advisory services on any matter relating to veterinary medicine and meat inspection in accordance with the provisions of the legislation on meat inspection. It is one of the mandates of the Veterinary Surgeons Council to determine the minimum standards of training required for degrees and diplomas holders so that they be registered to practice as veterinary para-professionals. The Council also determines the standards of professional conduct of persons practising as veterinary paraprofessionals.
SURVEILLANCE AND MONITORING
NOTIFIABLE DISEASES
The Diseases of Animal Act, 1977 and Diseases of Stock Regulations, 1926 are the principal legislations providing for the prevention and control of diseases of animals; importation, exportation and movement of animals; and the provision of quarantine of animals in certain circumstances. The Diseases of Animal Act recognises various diseases such as anthrax and foot and mouth disease.
Section 3 of the Diseases of Animals Act obliges every owner or person in control of any animal affected or suspected of being affected by any disease (listed in the Act) to report to the nearest departmental officer, administrative officer, or police officer and to isolate such animal. The Diseases of Stock Regulations requires the owner of any place or any owner of stock or any veterinary surgeon who may be called in by the owner has reason to suspect that any stock in his charge or possession or in respect of which he has been called in is suffering or has died from a disease, to forthwith in the speediest manner possible report the same to the nearest official and to isolate such animal. Additionally, Regulation 3 specifies a list of diseases that are considered notifiable diseases. This list includes diseases that are considered “diseases of economic importance”, these being diseases responsible for direct monitory loss and material loss such as foot and mouth disease.
The Regulations require that communities be notified in case of a particular place being declared an infected area and the name of the disease affecting the said area. When a notifiable disease has been identified or reasonably suspected, the law prohibits movement of infected stock from one place to another, and sale of stock with breeding diseases. For any disease outbreak, the Director of Veterinary Services determines the management of such outbreaks. The Diseases of Animals Act imposes criminal sanctions for violating the provisions of the Act, and offences attracts a fine not exceeding P5000 or to imprisonment for a term not exceeding five years, or to both; and to corporal punishment.
The Diseases of Animals Act obliges every owner or person in control of any animal affected or suspected of being affected by any disease to, as far as is practicable, keep such animal separated from other animals not so affected. Similarly, Regulation 32 of the Diseases of Stock Regulations imposes an obligation on the owner of animals to isolate the affected animal on becoming aware of the occurrence of disease.
The Diseases of Animals Act defines departmental officer to mean any veterinary officer, livestock officer, stock inspector or veterinary assistant employed by the Government. This means that the competent authority (government) is empowered to appoint veterinary inspectors to take actions necessary to ensure and enforce compliance with veterinary legislation. Additionally, the Veterinary Surgeon Act establishes the Council which is responsible for registration of veterinary surgeons or para-professional and encourages and promote efficiency in the practice of veterinary medicines.
Section 14 of the Diseases of Animals Act protects officials from legal action when exercising functions in good faith in connection with the diagnosis, control, prevention or treatment of disease (including the preparation of biological products). This provision ensures that officials can carry out their responsibilities without fear of legal consequences.
VETERINARY INSPECTION
Departmental officers are empowered to inspect any stock wherever such stock may be kept, driven or depastured. The purpose of such inspections is twofold. First, it to ascertain whether any stock is suffering from a disease. Second is to determine whether the regulations in respect to the cleaning and disinfection of the said place have been properly carried out. Further, the law grants departmental officers powers to access premises and vehicles for carrying out inspections, access documents, detain and seize stock, destroy infected stock or animals.
By virtue of departmental inspectors being government employee, they are bound by the Public Services Act, 2008. This Act enjoins them to utilise Government resources at their disposal in an efficient, responsible and accountable manner and to continuously improve their performance in delivering services. Also, conducts that tends to bring the public service into disrepute constitutes misconduct which attracts a disciplinary hearing, and penalties include dismissal. Other laws that restraints departmental officers from misusing their powers include the Penal Code, 1964 which prohibits abuse of office and the Corruption and Economic Crime Act, 1994 which criminalizes corruption.
DISEASE CONTROL
ZONING AND COMPARTMENTALIZATION
The Diseases of Animals Act (DAA) authorises the Director of the Department of Veterinary Services, including the Deputy Director of Veterinary Services and any veterinary officer authorized by the Director to declare any area to be an infected area. Once an area is declared an infected area, the authorities may impose the following measures: restricting movement of animals to and from the infected areas; isolation of infected animals; and ordering inoculation, dipping, treating or slaughtering of animals for the purpose of disease control. Specifically, when a place is declared as infected with Foot and Mouth Disease (FMD), the movement of cloven hooved animals in the infected areas is restricted. Persons leaving infected areas are expected to comply with reasonable precautions for preventing the spread of disease. Also, the carcass of any animal infected with disease shall be disposed of in accordance with any general or specific instructions issued by the departmental officer.
At District level, the Local Government Act, 2013 grants powers to the District Councils to take steps in addition to those taken by any other authority to safeguard and promote public health and prevent the occurrence of, or to deal with, any outbreak or prevalence of any disease. By virtue of this section, District Councils through the Council Secretary may declare an area as an infected zone to deal with the occurrence or prevalence of any disease
The Diseases of Animal Act also authorises the Minister to declare certain areas as stock-free zones for the purposes of controlling diseases. Fences may be erected and maintained and the sinking of boreholes within 8 km of any fence is prohibited. These zones act as buffer zones and the fences condones movement of animals from one zone to another. Also, the President in consultation with the Director of Veterinary Services, is authorised to establish compartments within country to prevent the introduction or spreading of any disease. Similarly, the Director of the Department of Veterinary Services may declare any area to be a disease free-zone.
CONTROL MEASURES
The Diseases of Animals Act and the Diseases of Stock Regulations provides the legal framework on diseases control measures. One of the control measures is the regulation of movement of people, and animals within, into and out of any zone. Where any areas have been declared infected, the District Officer of that district is required to notify the affected communities. The communication must be placed on easily accessible areas indicating the farms or places that have been declared infected. The Director may, by order published in the Gazette, for the purpose of preventing disease, prohibit the movement into or out of any infected area of any animal, carcass, litter, dung or fodder, except under a permit issued by a veterinary officer. Regulations authorise the competent authority to regulate movement of people, and animals in and out of any zone, in case of anthrax, breeding diseases, and foot-and-mouth disease.
The law also authorises the Director or other authorised officials to implement disinfection measures for the prevention of the spread of diseases. Further to this, the DAA authorises the Minister and Director to establish quarantine stations. The veterinary inspector may quarantine animals suspected to be suffering from specific diseases (anthrax, rinderpest, swine fever and swine erysipelas) or that have been exposed to the risk of contracting such disease. The owner of any animal held in quarantine is liable for all charges arising from any test, inoculation, dipping or treatment carried out while such animal is in quarantine.
The Diseases of Stock Regulations empowers departmental inspectors to treat or vaccinate animals for the purposes of disease control. The Director shall record in a database linked to an individual animal identification number of an animal, any vaccinations or other medical treatment and the specimen of the animal. An owner of an animal shall keep on an on-farm record for the animal information on any medical treatment of such animal, such as vaccinations, de-worming and dipping.
In terms of the DDA, compensation is only available in the case of an animal which, when slaughtered, is found not to be infected or likely to spread infection of any disease; and when animals which may be infected with disease are slaughtered in order to prevent the further spread of such disease. The Diseases of Stock Regulations provides for payment of compensation in specific circumstances. This compensation is from time to time determined by the government.
Violating any of the control measures provided in the Diseases of Animals Act attracts a fine of P5000 or imprisonment for a term not exceeding five years, or to both and to corporal punishment. Failure to comply with the Diseases of Stock Regulation attracts a fine not exceeding P100, for first offences. For second and subsequent offences, the penalty is imprisonment without the option of a fine, for a term not exceeding six months.
CONTINGENCY PLANNING AND EMERGENCY RESPONSE
CONTINGENCY PLANNING
The National Disaster Risk Management Plan (NDRMP) 2009-2014, provides for contingency plan, but does not define "contingency plans". It defines "contingency planning" as "a management process that analyses specific potential events or emerging situations that might threaten society or the environment and establishes arrangements in advance to enable timely, effective and appropriate responses to such events and situations." Botswana has contingency for the following diseases: Foot and Mouth Disease, Highly pathogenic avian influence (plan under review) and Peste des petits ruminants or goat plague (PPR).
EMERGENCY RESPONSE
In the absence of any specific legislation for disaster risk management, emergency responses are currently backed by the Constitution, the Emergency Powers Act,1966, the Public Health Act, 2014, and the National Disaster Risk Management Plan, 2009. The Constitution grants the President the powers to declare an emergency of any kind. Such an emergency may be revoked sooner than the stated duration. If not revoked it expires, at the lapse of the duration. However, the law does not state the conditions under which a declaration of a disease emergency must be revoked. The Emergency Power Act empowers the President to make emergency regulations specifying the emergency at hand. For disaster induced emergencies, the President will declare an emergency when the National Committee on Disaster Management (NCDM) has advised him to do so.
On the other hand, the Public Health Act empowers the Director of Health Services to declare a public health emergency where animal diseases affect public health. The emergency is called if the Director is satisfied that the situation so dictates and that it is not practicable for a declaration of a state of emergency or disaster to be made under the Emergency Powers Act. Section 23 of the Public Health Act require the declaration of emergency made by the Director be based on risk. The duration of such emergency is a maximum of seven days, may be extended as may be necessary. The law does not specify the conditions of revoking a declaration, serve to provide that it may be revoked sooner than the stated time. If not revoked it expires.
As per the National Disaster Risk Management Plan (NDRMP) once a declaration of an emergency has been proclaimed, such must be communicated to different stakeholders using various medium including Mass Messaging Systems (MMS) and at community gatherings organised to communicate the warnings and messages. The NDRMP empowers the competent authority to request assistance from other such as the police and military. These may offer transport and security services. Section 4 of the Emergency Powers Act empowers the President to put in place regulations necessary to control any risk, even if such measures are inconsistent with other enactments. Also, this law grants exceptional powers that may be exercised during an emergency, including animal diseases emergencies. These powers include the acquisition on behalf of the Republic of any property other than land.
IMPORT CONTROL AND EXPORT CERTIFICATION
IMPORT
The Disease of Stock Regulations regulates importation of animals into Botswana. Importation of stock and wild animals requires a permit issue by the Director of Veterinary Services and Director of Wildlife and National Parks, respectively. The importer may be requested to present a certificate from a government veterinary surgeon of the country of origin. The World Organisation for Animal Health (WOAH) Terrestrial Animal Health Code provide guidance on importation of animals.
The Diseases of Animals Act as read with the Diseases of Animals (Animal Information and Traceability System) Regulations (commonly referred to as BAITS), empowers the Director to designate ports of entry for the purpose of importation of any animal. All prospective importers of animals and animal products to be authorised by the Director. An application for an importation permit must state the number and kind of stock which it is desired to introduce, and their breed and sex, stating in the case of cattle whether they have been or are to be kept for dairying or beef purposes and the country and the particular district and farm, from which they come; and the route by which they will travel. In terms of the Wildlife Conservation and National Parks Act, 1992, a permit is required to import into or transport through or re-export from Botswana any wild animal, or trophy, meat or eggs thereof. All imported animals may be quarantined or detained at the border for an examination to ascertain if the stock is disease free. The Department of Animal Production issues import permits for domestic animals, while the Department of Wildlife and National Parks handles permits for wild animals. Subsequently, the Department of Veterinary Services conducts disease compliance vetting for all import permits.
The Public Health Act empowers the Minister, after consultation with the National Health Council, to prohibit, restrict or regulate the immigration or importation, into Botswana, of any animal, article or thing likely to introduce any communicable disease. The Customs Act empowers the inspector to refuse importation of all products on the grounds of protecting public health, to destroy or order return of the products at the importer's cost. Port Health Officers, who are authorized by the Public Health Act, are responsible for conducting inspections of products to ensure they meet health standards. It is an offence to fail to comply with the provisions of the Public Health Act, and the sanction is a fine not exceeding P5 000, or imprisonment for a term not exceeding 12 months, or both.
EXPORT
Currently, the Diseases of Animals Act require all prospective stock exporters of animals to be authorised by the Director of Veterinary Services, while the Control of Livestock Industry Act,1941 require all prospective exporters of cattle to be registered and granted in possession of an export permit issued by the Director of Veterinary Services. Similarly, the WCNPA require prospective exporters of wildlife products to get an export permit from the Director of Wildlife and National Parks. The law requires prospective exporters to acquire an export permit form a government veterinary officer for every case of export. The law requires inspection of any cattle or small stock for the purpose of acquiring an export permit. It is a criminal offence to attempt to export animals without a permit.
The Diseases of Stock Regulations provides for detention of stock at the border until examined by an official appointed for this purpose. Further to this, the Customs Act empowers the customs officer to carry out an inspection of goods and these includes animals and animals products, for customs purposes.
VETERINARY LABORATORIES
GENERAL PROVISIONS
The Diseases of Animals (Prohibition of use of Anabolic Hormones and Thyrostatic Substances) Regulations, 1987 defines an “approved laboratory" as a laboratory under the direct supervision of the Director of Veterinary Services. There is Botswana National Veterinary Laboratory (BNVL) under the National Agriculture Research and Development Institute (NARDI). The competent authority is Department of Veterinary Services under the Ministry of Agriculture. The BNVL is the sole confirmatory DVS diagnostic laboratory with two recently established satellite laboratories in the field. It handles samples from passive surveillance, clinical cases, disease surveillance programmes, and for food safety, particularly the control of food hygiene samples from export abattoirs. National and regional Foot-and-mouth disease (FMD)-specific diagnostic and investigatory needs, including post vaccinal monitoring, are carried out jointly by the Botswana Vaccine Institute (BVI) and the BNVL. Both laboratories have a mandate as OIE Reference Laboratories; BVI for FMD and BNVL for contagious bovine pleuropneumonia (CBPP). For veterinary purposes, the Director may authorise specific laboratories to process samples.
VETERINARY MEDICINAL PRODUCTS (VMP)
GENERAL PROVISIONS
The Medicines and Related Substances Act, 2013 provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances in Botswana. Section 3 of this Act establishes Botswana Medicines Regulatory Authority (BOMRA) as the competent authority responsible for regulation of all medicines and related substances in Botswana, including veterinary medical products.
REGISTRATION
The Medicines and Related Substances Act (MRSA), requires BOMRA to maintain a register of approved medicines including Veterinary Medical Products (VMPs). All medicines must be registered by BOMRA before being manufactured, stored, processed, distributed or sold. The registration is not time-limited, but he Authority may, by order published in the Gazette, declare any medicine to be a banned medicine, in which case the medicine c shall not be registered or if already registered, such registration shall be cancelled.
It is an offence to import, export, manufacture, distribute, sell, dispense, prescribe or advertise any medicine or other substance that is unregistered. The sanction is a fine of P100 000, or imprisonment for 10 years, or both. Additionally, the medicines may be seized and disposed at the request of BOMRA, and BOMRA may at the same time withdraw any approval or authorisation previously given by it to that person.
LICENSING
As per Medicines and Related Substances Act, all establishment that manufactures and dispenses medicines including VMPs must be licensed. The premises, where VMPs are sold, must be under the continuous supervision of a person authorised in writing by the Director of Veterinary Services. Failure to comply with any of the above requirements is a criminal offence which attracts a sanction of a fine not exceeding P15 000, or imprisonment for a term not exceeding three years, or both. Further, the Authority may suspend the license pending compliance with any directions it considers necessary, that the VMP facility is not being operated in accordance with good professional standards. In cases of non-compliance with the directives of BOMRA, the license may be cancelled, and the stock must be disposed within six months, in a manner approved by BOMRA. The import, export, distribute or sell medicines require a licence and shall be under the continuous supervisory control of a veterinary surgeon.
A person who contravenes these provisions commits an offence and is liable-in the case of import, export, distribution, or selling medicine, dispensing or keeping in storage contrary to such conditions as may be prescribed, any medicine after the date of expiry indicated on the package of the medicine, to a fine not exceeding P100 000, or to imprisonment for term not exceeding 10 years, or to both. BOMRA may withdraw a licence issued in terms of section 28 or 31 where it is satisfied that the medicine is being imported, exported, distributed or sold otherwise than in accordance with the conditions of a licence.
The law mandates the licensing of all establishments that manufactures medicines. The applicant must supply to BOMRA all information which indicates that the premises to be used are suitable for the purpose and will be operated in accordance with standards of good practice in the manufacturing and quality control of medicines. The manufacturing of medicines must be under the continuous supervisory control of a person authorised by the Director of Veterinary Services and possesses such practical experience as prescribed by BOMRA. BOMRA may cancel the licence where it is satisfied that the conditions of any licence are not being observed, or that the manufacture of any medicine is not being carried out in accordance with the provisions of MRSA or standards of good practice in the manufacture and quality control of medicines. Once a license has been cancelled, the licence holder shall cease all manufacturing.
SAFETY AND QUALITY CONTROL
The Medicines and Related Substances Act provides for safety and quality control measures on all medicines. BOMRA provides guidelines (Guideline for Good Manufacturing Practice- Document No: BOMRA/IL/IL/P08/G01) to all licensed and prospective manufacturers on the requirements for current Good Manufacturing Practice (cGMP).
The Medicines and Related Substances Act further requires any person who uses a veterinary medicinal product on an animal under his or her care or uses medicated feed to feed an animal that he or she keeps in a feed lot or other premises, to ensure that the animal is not slaughtered for consumption before the prescribed withdrawal period has elapsed, and the prescribed maximum residue limit allowable in meat has fallen within the limit allowed. A record of all medicines administered to animals must be kept by the owner.
The MRSA requires that labelling requirements must be in accordance with the requirements imposed by the Authority. These labelling requirements set forth in the Medicines and Related Substances Regulations. Amongst the labelling requirements is the information indicating the manufacturer; expiry date; any special storage conditions; any warnings or precautions; and any directions for use if sold without prescription. The Medicines and Related Substances Regulations indicates that the disposal of medicines must be in line with the guidelines set by the Authority. These guidelines are readily available on BOMRA’s website and constantly updated. Changing the manufacturing process, labelling, or packaging of a medicine without the prior authorization of BOMRA is an offence that attracts a fine not exceeding P50 000, or imprisonment for a term not exceeding three years, or both. Furthermore, the Act grants BOMRA the power to seize and dispose of medicines, as well as revoke any prior approvals or authorizations granted by it to an individual.
PRESCRIPTION AND USE
The Medicines and Related Substances Act (MRSA) permits veterinary surgeons to prescribe Veterinary Medicinal Products to all animals whether under their care or not. The MRSA as read with the Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 - Document No: BOMRA/IL/IL/P03/G01 indicates the medicines that may only be taken on prescription. These medicines are listed in Schedules 1A, 1B, 1C and 1D; 2 and 3. Dispensing of the Schedule 1A, 1B, 1C and 1D medicines is only done against a written prescription from a registered Veterinary Surgeon, whereas Schedule 2 and 3 medicines and vaccines may be prescribed by a registered Veterinary Surgeon or an authorised paraprofessional. Dispensing Schedule 4 veterinary medicines does not require a prescription. The law requires prescribers to keep a copy of each issued prescription for a period of one year. The MSRA imposes criminal sanctions for offences related to VMPs' prescription and use regulations. The sanction is a fine not exceeding P5 000 or imprisonment for a term not exceeding one year, or both. Also, the Authority may at the same time withdraw any approval or authorisation previously given by the Authority to that person.
PHARMACOVIGILANCE AND RECALL
The Medicines and Related Substances Act obligates any person who believes that an animal has suffered an adverse reaction from receiving a Veterinary Medicinal Products, or that a person has experienced an adverse reaction from handling a Veterinary Medicinal Products, to report to BOMRA. A report has to be made also when the adverse reaction is as a result of clinical trials. BOMRA may, without prior consultation from the holder of market authorisation, recall a medicine. Further, holders of market authorisation upon being aware of a safety, efficacy or quality problem which could have detrimental effects on public health are obliged, in consultation with the Authority, to recall the medicine. Failure to report and recall by holders of market authorisation is an offence which attracts a fine not exceeding P100 000 and imprisonment not exceeding 10 years., or both. The Act further authorises, BOMRA to withdraw any rights and licenses granted to the license holder as a result of violating the law.
IMPORT
The Medicines and Related Substances Act (MRSA) and the Medicines and Related Substances Regulations as read with the Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 provides the legal framework on importing VMPs. The Guidelines incorporates the WHO guidelines on import procedures for Medicines No 917, 2003. According to the MSRA, all individuals aspiring to import VMPs must acquire import licenses, and it is mandatory for the importer to be a resident of Botswana. All VMPs to be imported must be registered by Botswana Medicines Regulatory Authority (BOMRA). The law requires that the importation be under the continuous supervisory control of a veterinary surgeon. Also, importation of medicines must be done by importers whose premises are dully licensed by BOMRA. The importation of all consignments of medicinal products is channelled through the designated ports of entry and are cleared by customs and the Ministry of Health (Port Health) in consultation with BOMRA. Upon arrival at the ports, the medicines are inspected by the BOMRA, Customs or Health inspector to ensure that they comply with the approved specifications and regulations before they are released. The Customs Act, 2018empowers the Commissioner General to arrange for destruction of VMPs to safeguard public health. Failure to adhere to the import regulations is an offence which attracts a sanction of a fine not exceeding P100 000, or imprisonment for a term not exceeding 10 years, or both. In the event that an individual is found guilty, the MSRA has the authority to request the court to order the seizure and disposal of the VMPs and determine the method of disposal. In addition, the Authority has the power to revoke any approval or authorization previously granted to the person in question.
EXPORT
Exportation of VMPs is regulated by the Medicines and Related Substances Act (MRSA) and the Medicines and Related Substances Regulations as read with the Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01. In terms of the MSRA all exporters of VMPs must obtain export licenses for each consignment. The Customs and Excise Regulations permits the inspection of export wherever the Authority deems it fit. Failure to adhere to the export regulations is an offence which attracts a sanction of a fine not exceeding P100 000, or imprisonment for a term not exceeding 10 years, or both. Also, where the person is found guilty, the Authority may request the court for an order to seize and dispose the VMPs. The Authority may at the same time withdraw any approval or authorisation previously given by the Authority to that person.
In terms of the Medicines and Related Substances Act, the import of medicines must be under the control of a veterinary surgeon. A " “veterinary surgeon” means a person registered as a veterinary surgeon under the Veterinary Surgeons Act (Cap. 61:04). Therefore, prospective importer must be registered as veterinary surgeons.
INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH
INSTITUTIONAL SET-UP
The Diseases of Animals Act defines the powers of the Minister, Director and departmental officer in relation to animal health. The powers of the Minister include establishing quarantine stations and declaring stock-free zones for the purpose of the disease control. Departmental officers have the powers to instruct the owner of any stock to assemble such stock or any part thereof at any specified place for the purpose of inspection or inoculation. They also enter on any land, building, shed, place, carriage, van, truck, vessel or aircraft containing or conveying or used for conveying animals for the purpose of inspecting or examining any stock, carcass, article or vehicle to ascertain whether or not the provisions of this Act are being properly carried out. The VSA establishes the Council which responsibilities include registration of Veterinary surgeons and encourages and promote efficiency in the practice of veterinary medicines, whereas the MRSA establishes the Medicines Regulatory Authority (BOMRA) as the competent authority responsible for regulation all medicines and related substances in Botswana, including veterinary medical products.
District Councils have been granted powers under the Local Government Act, 2013 to protect and promote public health at the district level. This includes taking additional measures beyond those taken by other authorities to prevent the occurrence of diseases or address outbreaks. By utilizing this authority, District Councils, through the Council Secretary, have the ability to declare an area as an infected zone in order to effectively address and manage the occurrence or prevalence of any disease within that area. Additionally, the Act provides for the establishment of a law enforcement office in every Council which consists of law enforcement officers whose main duties are to enforce the Council’s regulations and directives. They have the power to arrest, enter, search, and seize any goods and properties.
The Public Health Act defines the powers of the Minister of Health, Director of Health Services, Health Officers, and Port Health Officers. The Minister may, after consultation with the National Health Council, prohibit, restrict, or regulate the immigration or importation of any animal, article, or thing that may introduce a communicable disease into Botswana. The Minister is also authorized to take precautionary measures to prevent the introduction of communicable diseases. The Director of Health Services serves as the primary technical advisor on national health issues and oversees the inspection, sampling, and examination of vaccines used for the prevention and treatment of animal diseases. Health officers are responsible for notifying the Director of Health Services about any abnormal sickness or mortality in animals. The Act also outlines the powers and responsibilities of Port Health Officers at entry ports, including implementing port health programs, ensuring compliance with public health laws, detaining, and reporting quarantinable diseases, and conducting inspections to enforce the provisions of the Public Health Act.
The Botswana Unified Revenue Service (BURS) is a crucial institution involved in the importation and exportation of VMPs. BURS serves as the initial point of contact for imported medicines, and its Commissioner General has the authority to refuse the importation of VMPs and order their destruction in order to protect public health.
The Ombudsman Act creates the office of the Ombudsman. Its tasks include investigating complaints against governmental departments and private entities and offer suitable reliefs. The Veterinary Surgeon Council established in terms of the Veterinary Surgeons Act provides for the establishment of a Grievances and Disciplinary Committee to investigate disciplinary cases and imposing penalties on persons who contravene this Act.
INSTITUTIONAL COOPERATION AND COORDINATION
The Medicines and Related Substances Regulations provides for collaborations with other authorities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of resources. One instance in which coordination is essential is the importation and exportation of medicines and related substances. The Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 and the Guideline for facilitation at Port of Entry, 2021 - Document No: BOMRA/IL/IE/P05/G03 provides for the roles of the different parties, chiefly customs officials, Port Health Officials and Botswana Medicines Regulatory Authority (BOMRA).The latter guidelines defines areas of cooperation and role clarity between BOMRA and Port of Entry (PoE) personnel (customs officers and Port Health officers) to ensure seamless operations at port of entry; and highlights and describes activities to be undertaken at PoE and clarify who will carry out the activities. The guidelines indicate that customs (BURS) will be the first point of contact for imported medicines. Upon identifying the consignment as medicines and related substances, BURS will forward the same to Port Health for document verification and inspections.
The Public Health Act facilitates cooperation between the Director of Health Services and local authorities in the designation of environmental health officers by the Director of Health Services. These officers are responsible for exercising control over environmental health matters. Furthermore, the Director collaborates with the departments responsible for customs and immigration, as well as other relevant authorities, to establish points of entry for the provision of port health services.
DELEGATION OF POWERS
The law on animal health provides for the delegation of powers. The Diseases of Animals Act allows the Director of Veterinary Services to delegate his authority to any person. Similarly, the Medicines and Related Substances Regulations allow the Chief Executive Officer to delegate the exercise of any of his or her powers under this Act to any senior officer of the Authority. The Diseases of Stock Regulations of 1926 empower the Minister to delegate his functions to any person by name for a period not exceeding three months at any one time, subject to conditions, exceptions, and qualifications as prescribed. Under the Public Health Act, the Director of Health Services may delegate any of his or her functions or powers under this Act to any person, class of persons, public authority, or agency in writing. The Local Government Act allows the Council to delegate its functions to bodies, trusts, and other bodies established by it, as well as to any other person in accordance with Government policies. The Council may revoke or amend any delegation with reasons and attach conditions to the delegation, including general or directions on how to exercise the delegated power.